Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.

Recall Insight

This FDA Devices action (record #Z-0008-2014) was formally reported on October 16, 2013, with the manufacturer initiating the action on August 14, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Draeger Medical, Inc. is listed as the recalling firm, operating out of Telford, PA. Federal records indicate 1127 units units are affected.

The documented reason for this recall is: During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit… Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany, Greece, Hungary, India…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.